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The purpose of this study is to assess the effectiveness of the Small Changes program in facilitating weight loss and to assess treatment effects on body composition, blood markers of metabolic health, and blood pressure, and to assess attrition and compliance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small Changes program | Experimental |
| |
| Standard behavioral therapy for weight loss | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small Changes program | Behavioral | Participants will be asked to track their compliance with their Small Changes diet plan using a simple checklist record . Participants will be asked to follow their diet plan every day. They are encouraged to create a diet plan that is as close to their current diet as possible. Meal options include make-from-scratch recipes, quick "grab-and-go" options,and restaurant options. There may be some time involved in learning the recipes and the routine of their new diet. It also may alter their grocery spending and habits somewhat |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Baseline,12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1C levels | Baseline, 12 weeks | |
| Change in triglycerides levels | Baseline, 12 weeks | |
| Change in total cholesterol levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leah Whigham, PhD | Contact | (915) 975-8517 | Leah.D.Whigham@uth.tmc.edu | |
| Juan Aguilera | Contact | (915) 975-8520 | Juan.Aguilera@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Leah Whigham, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Standard behavioral therapy for weight loss | Behavioral | Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes. |
|
| Baseline, 12 weeks |
| Change in HDL cholesterol levels | Baseline, 12 weeks |
| Change in fasting blood glucose levels | Baseline, 12 weeks |
| Change in lean body mass | baseline, week 4, week 8, week 12 |
| Change in fat mass | baseline, week 4, week 8, week 12 |
| Compliance as measured by the percentage of meals that follow the diet plan as reported in a daily food log | From baseline to week 12 |
| Attrition as assessed by number of participants that complete the study | week 12 |
| Texas Tech University | Lubbock | Texas | 79424 | United States |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |